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ALACHUA – Bioservices Inc., a biologics contract development and manufacturing organization (CDMO), announced it has been awarded a contract to advance development of a cocktail of anti-botulinum neurotoxin monoclonal antibodies (mAb) by the Department of Defense (DOD) through the Joint Science and Technology Office of the Defense Threat Reduction Agency (DTRA) and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). The contract ceiling value is $42.6 million. 

In this program, Ology Bioservices will execute a randomized, double-blinded Phase 1 dose-escalation clinical trial of a cocktail of mAb against botulinum neurotoxin serotypes A and B. In addition, the company will further refine the manufacturing process for the mAb as well as conduct nonclinical studies to support advanced development of the product. The candidate was originally developed by Xoma Corporation and later acquired by Ology Bioservices.

Ology Bioservices successfully transferred the technology and manufactured this candidate therapeutic for the DOD under a previous contract awarded in 2017.

“This contract is an important milestone for both Ology Bioservices and the DOD,” said Peter H. Khoury, Ph.D., President and Chief Executive Officer of Ology Bioservices. “Monoclonal antibodies represent an important, innovative option in medical countermeasure development, allowing the DOD to more effectively layer CBRN defense. We are excited to bring this next generation of countermeasure to the clinic.”

About Ology Bioservices

Ology Bioservices is a privately held, full-service Contract Development Manufacturing Organization (CDMO) serving both government and commercial clients, specializing in biologic drug substance manufacturing from early stage through commercial product. The company has 183,000 square feet of manufacturing, process development and QA/QC space in its state-of-the-art Advanced Development and Manufacturing Facility in Alachua, Florida.

The company’s infrastructure provides unique services to its clients, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as CGMP manufacturing up to Biosafety Level 3 (BSL3). Ology Bioservices has more than 20 years of experience developing and manufacturing drugs and biologics for the U.S. government, with over $1.8 billion in government contracts awarded. The team at Ology Bioservices has decades of experience manufacturing, developing and licensing vaccines and protein/antibody therapeutics. For more information, visit the company’s website at www.ologybio.com.

About DTRA

The Defense Threat Reduction Agency enables the Department of Defense, the United States Government, and international partners to counter and deter weapons of mass destruction (WMD) and improvised threat networks.

Countering WMD and improvised threats is a global problem that requires DTRA’s unique global presence and execution capabilities. As a Combat Support Agency, DTRA provides various forms of support to the Combatant Commands (CCMDs) and the military services with both defensive and offensive capabilities. The agency is uniquely prepared to address some of the most immediate, consequential, and non-conventional weapon threats to national security through leveraging and expanding collaboration with interagency and international partners.

As the DoD’s research and development leader focused on WMD and improvised threats, DTRA facilitates innovation through combining traditional research with unconventional means to develop and quickly field solutions to the most complex, deadly and urgent threats facing the United States and the rest of the world.

DTRA has over 2,000 uniformed military personnel and DoD civilians working on every continent except Antarctica. The agency has thousands of global engagements in more than 100 countries and in addition to multiple locations stateside and overseas, the agency has liaisons in many embassies.

About the JPEO-CBRND

The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) is the DOD Joint Service’s lead for development, acquisition, fielding and life-cycle support of chemical, biological, radiological, and nuclear defense equipment and medical countermeasures. As an effective acquisition program, the JPEO-CBRND puts capable and supportable systems in the hands of the service members and first responders, when and where it is needed, at an affordable price. Our vision is a resilient Joint Force, enabled to fight and win unencumbered by a chemical, biological, radiological, or nuclear environment, championed by innovative and state-of-the-art solutions.

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NEWBERRY - The City of Newberry reports that one a team member has tested positive for COVID-19. This employee was working in City Hall and was last in a city facility on June 18. The positive result was confirmed over the weekend. Because of privacy laws, specific details about the employee will not be released.

Newberry officials state, "Our top commitment is to the safety of our customers, neighbors, and employees. As a result, we want to reassure you that the employee is under quarantine and being monitored by health professionals. A detailed contact tracing is being performed by health officials to identify others who may have come in close contact with the infected employee. Employees who worked closely with this employee are being tested and quarantining. If you have concerns about your exposure, please contact your medical professional or the Department of Health."

The City of Newberry will continue to follow CDC guidelines for workplace safety, require employees to use facial coverings, promote good hygiene practices and share health, safety and travel guidelines with all employees.

Officials further state, "We want to reassure our residents that there is staff on hand for ongoing operations and customer service inquiries. Many departments are working from remote locations until the pandemic eases. We are here and working to support you every day."

As a precaution, City Hall has been closed to visitors and customers due to the exposure, but the drive-thru is available for customers wishing to make payments. The City is working with professional cleaners to disinfect the building before re-opening.

The City of Newberry encourages the community to practice social distancing by making account inquiries or paying bills online or by phone to help flatten the curve of COVID-19. For questions about Newberry’s efforts during the COVID-19 pandemic, visit www.ci.newberry.fl.us or call 352-472-2161.

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GAINESVILLE – After weeks of intensive work that included reviews of return-to-school plans from districts across Florida and other states, surveys of families and staff, consultations with local healthcare experts and guidance from the Florida Department of Education, Alachua County Public Schools has released a draft plan for the reopening of schools in the fall of 2020. That plan is available on the district’s website at https://fl02219191.schoolwires.net/Page/30007.

The plan outlines strategies that will be implemented depending on the community spread of the virus—no spread, minimal/moderate spread and significant spread. According to the Alachua County Health Department, Alachua County is currently in the minimal/moderate spread category, although that could change.

The plan also offers families different educational options ranging from in person instruction to a Digital Academy to enrollment in the Alachua eSchool. Under the Digital Academy option, students would receive individualized instruction at home, including live lessons. Students would be expected to be engaged in digital learning following their typical school schedule—for example, 7:45 a.m. to 1:52 p.m. for most elementary schools.

Students enrolled in Alachua eSchool would receive virtual instruction from eSchool teachers which allows for more flexibility, particularly in terms of a schedule. Alachua eSchool has been in place for several years and currently serves about 3,000 full- and part-time students.

More information on all options will be provided to all families during the week of July 6.

A survey previously sent to parents showed a plurality of the more than 12,000 respondents (about 36 percent) completely supported a return to in-person schooling with precautions, including frequent handwashing and enhanced cleaning of facilities, while about 26 percent did not.

“We recognize that no single plan will meet every family’s needs, particularly in this very challenging environment,” said Superintendent Karen Clarke. “What we’ve tried to create is a draft plan that provides options and covers a variety of scenarios depending on the course of the virus.”

The draft plan has been reviewed by the Alachua County Health Department and the district’s medical director, a pediatrician with UF Health. District staff will remain in constant contact with local healthcare professionals about COVID-19 and its impact on schools.

The district will be seeking more input from staff, families and the community before the plan is finalized, which is scheduled for July 15. A school board workshop on July 8 at 2 p.m. will include a presentation on the draft plan, including the instructional options, and an opportunity for citizens to comment and ask questions. That workshop will be held online and will be open to the public. In the meantime, citizens can submit their input at returntoschool@gm.sbac.edu.

The district currently plans to reopen schools to students on Aug. 10. Emails, texts and phone messages with a link to the plan are being sent to all families in the district.

“Ultimately our goal is to provide a high-quality education and other critical services to our students while promoting their health and well-being and that of our families and staff,” said Clarke.

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HIGH SPRINGS – The High Springs City Commission has set the date of Nov. 3 for the City’s 2020 municipal election. The two commission seats expiring this year are Seat #1, currently occupied by Commissioner Nancy Lavin, and Seat #2, presently held by Vice-Mayor Gloria James.

Resolution 2020-C sets the qualifying period to begin during business hours on Monday, July 20 and ending at the close of business on Thursday, July 23, 2020.

Any High Springs citizen who is registered to vote may run for a Commission seat by filing the necessary qualifying papers provided in Florida Statutes with the High Springs City Clerk’s office during the qualifying period.

Candidates must file a Statement of Financial Interests Form, notarized Loyalty Oath/ Oath of Candidate, Affidavit of Residency and pay the qualifying fee or file a waiver (Affidavit of Undue Burden). They must also submit an Appointment of Campaign Treasurer and Designation of Depository and Statement of Candidate forms.

An appointment of Campaign Treasurer and Designation of Campaign Depository form must be filed before opening a campaign account. Candidates may submit the form at any time during the qualifying period. The filing of this form triggers the requirement to file the treasurer's reports. Candidates may not collect or spend money on their campaign until after submitting this form.

The qualifying fee for running for City Commissioner is $108, which is one percent of the $10,800 salary of the office sought.

Questions may be directed to the City Clerk’s Office at High Springs City Hall.

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• A child is less than two years old
• An individual has one or more medical conditions or disabilities that prevent him from wearing a face covering
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